MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-10-20 for SEDASYS CASSETTE, DRUG DELIVERY SEDCAS01 manufactured by Ethicon Endo Surgery, Inc (cincinnati).
[20012725]
It was reported that after a diagnostic procedure, the drug delivery cassette labeled? Stop sample, not for sale. Caution: non sterile not for human use? Was used on the patient. The propofol in the tubing set was cultured by the hospital and no growth was observed. The physician has confirmed that there was no patient impact. The cassette was previously supplied to the facility for use during installation and training of the system. There are no remaining? Not for human use? Cassettes in the facility
Patient Sequence No: 1, Text Type: D, B5
[20181885]
(b)(4); device was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1527736-2014-00027 |
| MDR Report Key | 4185723 |
| Report Source | 05,06,07 |
| Date Received | 2014-10-20 |
| Date of Report | 2014-09-26 |
| Date of Event | 2014-09-26 |
| Date Mfgr Received | 2014-09-26 |
| Date Added to Maude | 2014-10-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GUILLERMO VILLA |
| Manufacturer Street | ROUTE 22 WEST PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082180707 |
| Manufacturer G1 | AVAIL MEDICAL |
| Manufacturer Street | 8572 SPECTRUM LN |
| Manufacturer City | SAN DIEGO CA 92121265 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 2652 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEDASYS CASSETTE, DRUG DELIVERY |
| Generic Name | CASSETTE, DRUG DELIVERY |
| Product Code | PDR |
| Date Received | 2014-10-20 |
| Model Number | NA |
| Catalog Number | SEDCAS01 |
| Lot Number | 20231327R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO SURGERY, INC (CINCINNATI) |
| Manufacturer Address | 4545 CREEK RD CINCINNATI OH 45242280 US 45242 2803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-20 |